FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
30337–30360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2016
Xcite Clinical Station
K160614 · IPF
Restorative Therapies, Inc.
Physical Medicine · 288d
Cleared Dec 16, 2016
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · NBW
I-Sens, Inc.
Chemistry · 274d
Cleared Dec 16, 2016
HyperView Hyperspectral Tissue Oxygenation Measurement System
K161237 · MUD
Hypermed Imaging, Inc.
Cardiovascular · 228d
Cleared Dec 16, 2016
Dentium CAD/CAM Abutments
K161713 · NHA
Dentium Co., Ltd.
Dental · 178d
Cleared Dec 16, 2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
K161837 · JGS
Beckman Coulter, Inc.
Chemistry · 164d
Cleared Dec 16, 2016
Chagas Detect Plus Rapid Test
K161947 · MIU
InBios International, Inc.
Microbiology · 155d
Cleared Dec 16, 2016
VITROS Chemistry Products Cl- Slides
K162020 · CGZ
Ortho-Clinical Diagnostics
Chemistry · 148d
Cleared Dec 16, 2016
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable...
K162161 · GZB
Stimwave Technologies Incorporated
Neurology · 136d
Cleared Dec 16, 2016
Somatom Confidence ® RT Pro
K162302 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Dec 16, 2016
LC Bead LUMI
K162373 · KRD
Biocompatibles UK Limited
Cardiovascular · 114d
Cleared Dec 16, 2016
Zerona Z6 OTC
K162578 · OLI
Erchonia Corporation
General & Plastic Surgery · 92d
Cleared Dec 16, 2016
CETRA Anterior Cervical Plate System
K162638 · KWQ
Orthofix, Inc.
Orthopedic · 85d
Cleared Dec 16, 2016
Revolution CT
K163213 · JAK
Ge Medical Systems, LLC
Radiology · 30d
Cleared Dec 16, 2016
COOLIEF Cooled Radiofrequency Kit
K163236 · GXI
Halyard Health, Inc.
Neurology · 29d
Cleared Dec 15, 2016
MRidium 3860+ MRI infusion Pump/ Monitoring System
K143369 · FRN
Iradimed Corporation
General Hospital · 751d
Cleared Dec 15, 2016
IPS e.max® Press Abutment Solutions for Viteo Base Ti
K160798 · NHA
Ivoclar Vivadent, AG
Dental · 267d
Cleared CT Dec 15, 2016
Menai System
K160836 · BZD
Resmed, Ltd.
Anesthesiology · 265d
Cleared Dec 15, 2016
WS(TM) Far-Infrared Therapy Unit, Model KP-B210
K160849 · ILY
Ws Far IR Medical Technology Co., Ltd.
Physical Medicine · 262d
Cleared Dec 15, 2016
Zia
K160852 · LLZ
Zetta Medical Technologies, LLC
Radiology · 262d
Cleared Dec 15, 2016
Arthrex iBalance UKA System Vitamin E Tibial Bearing
K161060 · HSX
Arthrex, Inc.
Orthopedic · 244d
Cleared Dec 15, 2016
BluePro
K162192 · LRK
Bluesom
Dental · 133d
Cleared Dec 15, 2016
PERMATAPE
K162247 · GAT
Medos International SARL
General & Plastic Surgery · 127d
Cleared Dec 15, 2016
Pulsaderm ACE-All Blue
K162371 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 113d
Cleared Dec 15, 2016
INTRABEAM 600
K162568 · JAD
Carl Zeiss Meditec, AG
Radiology · 92d